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A clinical trial to study two different types of intravenous fluids for maintenance fluid treatment of children

Randomized Controlled Trial Comparing Isotonic and Hypotonic Intravenous Fluids for Maintenance Fluid Therapy in Children

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/000398
Enrollment
60
Registered
2010-12-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E871- Hypo-osmolality and hyponatremia Health Condition 2: R69- Illness, unspecified

Interventions

Intervention1: Isotonic Saline Solution (0.9% NaCl Solution In 5% Dextrose): 60% Of The Maintenance Fluid Requirement (Calculated By Holiday And Segar Formula) for 48 hours Control Intervention1: Hypo

Sponsors

Jawaharlal Nehru Medical College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children in the age group of 0.5 to 12 years who are admitted and anticipated to receive intravenous fluid for the next 48 hours

Exclusion criteria

Exclusion criteria: 1)Baseline serum sodium concentration less than 130 mmol/L or greater than 150 mmol/L 2)Hemodynamically unstable patients: shock, myocarditis, congestive heart failure 3)Acute gastroenteritis with dehydration 4)If intravenous fluid has been administered within the 3 hours preceding the study 5)Acute or chronic kidney disease, a history/evidence of cardiac dysfunction, severe chronic neurological illnesses (uncontrolled seizure disorders, severe developmental delay), diabetes mellitus or insipidus 6)Pre-existing hypertension, diuretic use, edema, or known adrenal dysfunction

Design outcomes

Primary

MeasureTime frame
Incidence of hyponatremiaTimepoint: 24 and 48 hours after initiating intervention

Secondary

MeasureTime frame
Blood: sodium,potassium, chloride, pH, urea, serum creatinine. Urine output,weightTimepoint: 12 hourly;Manifestations attributable to dysnatremias,Case fatality rateTimepoint: During the study observation period;Serum osmolalityTimepoint: 24 hourly

Countries

India

Contacts

Public ContactDr. Kamran Afzal

Reader, Department of Pediatrics

drkafzal@hotmail.com0571-2721182

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026